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Correspondence |

Palliating Predatory Practices and Protecting Professionalism FREE TO VIEW

Constantine A. Manthous, MD, FCCP
Author and Funding Information

FINANCIAL/NONFINANCIAL DISCLOSURES: None declared.

CORRESPONDENCE TO: Constantine A. Manthous, MD, 6 Hemingway Rd, Niantic CT 06357


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016;149(4):1113-1115. doi:10.1016/j.chest.2016.01.034
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I applaud the prescription of Liss et al for reducing wasteful medical spending on ineffective and/or overpriced medications. To remind readers, they wrote a letter praising Mark Metersky’s denunciation of Mallinckcrodt Pharmaceutical’s campaign to promote use of their very expensive products (Acthar, adrenocorticotropic hormone) to treat sarcoidosis. I agree wholeheartedly with their conclusion that physicians who prescribe useless medications are unprofessional.

But why focus only on physicians? The authors mention that the US Food and Drug Administration (FDA) cannot, by statute, consider cost or cost-effectiveness when considering medications for approval. The FDA is an arm of our government and, as such, should not approve medications for uses for which there is no prospective randomized evidence of effectiveness. Time-limited exceptions can be made for compassionate use of drugs with great promise that are in the pipeline of appropriate testing. However, if a statute requires the FDA to approve useless medications they are then, by law, required to disserve both the health and the finances of the public. If so, the statute is broken and should be repaired.

Insurers should not pay for medications that have not shown substantial benefits to patients. Because the government is the biggest insurer, it should lead the way. Unfortunately, too many politicians have assailed the Patient Protection and Affordable Care Act’s comparative effectiveness research, under the pretense it would entail rationing. Rather, these same politicians have protected prices that are not in the best interest of patients. Politicians who stand for PhRMA over patients should be exposed in public media.

Finally, the medical establishment should take a strong stance against physicians who prescribe medications that have no benefits and should renounce companies that push useless or harmful medications. Liss et al suggest predatory pricing of Acthar ($25,000-$50,000 according to their report). If journals and medical societies do not renounce predatory pricing and unethical practices to fool (foolish) physicians into prescribing expensive useless medicines, who will? So we lose a few dollars of advertising revenue; there aren’t many companies acting so egregiously. If our professional societies cannot take a stand, why not? And if they can’t or won’t, then who will have the ethical high ground to chastise physicians who misbehave? One feature of a profession is its ability to police members; if we have outsourced this function, who owns it now? If all professional societies and journals stand together for just this single cause, few are likely to balk.

Although some readers are sure to find my prescriptions extreme, they seem to be common sense to me:

  • 1.

    Professional societies—all together and with one voice—should renounce predatory pricing and refuse to permit companies that push useless drugs at inappropriate prices to buy advertising space in journals or to participate in professional meetings. Professional societies have far more leverage in this system than they choose to exercise. All but a small minority of companies would fall into line because it would be “bad business” (ie, financially unfeasible to bear a public scarlet letter). Moreover, professional societies could also formulate lists of medications and average costs for various disciplines, coupled with an objective summary of their benefit. Some clinicians may not be aware of the costs of some of their prescriptions, and these behaviors might be affected by simply bringing awareness to costs.

  • 2.

    The Choose Wisely campaign and consensus documents should be distilled to list those drugs and interventions that do not serve patients or which harm patients. Let us then add a statute that makes sense: physicians who order medications or interventions on the list should be at risk of having to pay the bill if discovered. Some patients might not know any better, but we should. I have heard the argument that patients come in demanding/expecting X, Y, or Z. If so, we have the responsibility to educate them about why we will not prescribe it. Z-Paks (Pfizer) for the common cold would soon become an anachronism, simultaneously protecting patients, taxpayers, and the biosphere.

  • 3.

    Although insurers could send bills for useless prescriptions to physicians, they could simultaneously notify state credentialing agencies. Physicians with large numbers of such prescriptions could be targeted for ethical/medical review of their practices by licensing boards. Ordinary people, without hidden conflicts of interest, are sure to object to medications at $25,000 per dose without proven (and very substantial) benefit.

  • 4.

    The FDA should approve only medications that are shown to improve a patient’s outcomes, not relative to placebo but to standard of care. Although “noninferiority” is a reasonable threshold for approving drugs of the same class as those already proven effective (to encourage competition), it should not be a sufficient condition for approval of new classes of medications. New classes should only be approved after they have demonstrated substantial advantages in head-to-head trials with the standard of care. These standards should also be extended to medical devices.

  • 5.

    Medications or devices for which there are monopolies should be regulated. Market mechanisms to define “fair price” fail with monopolies. It is a proper role of government to defend taxpayer’s from market failures; we accept this scenario in most other industries, and health care should be no exception.

I’m certainly missing other concrete common sense solutions, and I hope my article will provoke others to chime in. But until we reassume our professional responsibilities individually and collectively, and assert ourselves to reformulate public policies that make sense, we will remain frustrated and marginalized.

References

Liss D. .Brennan T.A. .Manker S. . Finding common ground: professionalism and Acthar prescribing practices. Chest. 2016;149:611-612 [PubMed]journal. [CrossRef] [PubMed]
 
Metersky M.L. . Is there any reliable clinical evidence to suggest that Acthar is more effective than other forms of corticosteroids in treating sarcoidosis and other diseases it is being marketed to treat? Chest. 2016;149:886- [PubMed]journal. [CrossRef] [PubMed]
 
Highlights of prescribing information: Acthar gel.http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022432s000lbl.pdf. Accessed January 21, 2016.
 
Vijay M.R. .Levin D.C. . The overuse of diagnostic imaging and the Choosing Wisely initiative. Ann Intern Med. 2012;157:574-576 [PubMed]journal. [CrossRef] [PubMed]
 
Harris AM, Hicks LA, Qaseem A; High Value Care Task Force of the American College of Physicians and for the Centers for Disease Control and Prevention. Appropriate antibiotic use for acute respiratory tract infection in adults: advice for high-value care from the American College of Physicians and the Centers for Disease Control and Prevention [published online ahead of print January 19, 2016].Ann Intern Med.http://dx.doi.org/10.7326/M15-1840.
 

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References

Liss D. .Brennan T.A. .Manker S. . Finding common ground: professionalism and Acthar prescribing practices. Chest. 2016;149:611-612 [PubMed]journal. [CrossRef] [PubMed]
 
Metersky M.L. . Is there any reliable clinical evidence to suggest that Acthar is more effective than other forms of corticosteroids in treating sarcoidosis and other diseases it is being marketed to treat? Chest. 2016;149:886- [PubMed]journal. [CrossRef] [PubMed]
 
Highlights of prescribing information: Acthar gel.http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022432s000lbl.pdf. Accessed January 21, 2016.
 
Vijay M.R. .Levin D.C. . The overuse of diagnostic imaging and the Choosing Wisely initiative. Ann Intern Med. 2012;157:574-576 [PubMed]journal. [CrossRef] [PubMed]
 
Harris AM, Hicks LA, Qaseem A; High Value Care Task Force of the American College of Physicians and for the Centers for Disease Control and Prevention. Appropriate antibiotic use for acute respiratory tract infection in adults: advice for high-value care from the American College of Physicians and the Centers for Disease Control and Prevention [published online ahead of print January 19, 2016].Ann Intern Med.http://dx.doi.org/10.7326/M15-1840.
 
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